Key facts
| Firm | BSO, LLC |
|---|---|
| FEI / inspection ID | 3030548360 |
| Inspection end date | June 27, 2025 |
| Citation count | 8 |
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting to be
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process. Specifically, Your firm failed to establish and document adequate validation of the IDJ14J I sterilization process used for Estradiol Pellets (6 mg, 10 mg, 12 .5 mg, 15 mg , 18 mg, 20 mg, 25 mg , 37.5 mg, 50mg). a.You implemented a new container-closure system for Estradiol Pellets, but your sterilization validation (BSO.ST.002.1R) did not include a method suitability study or calculation of a recovery factor (RF) to assess the efficiency of microbial recovery from the new configuration. Additionally, your firm has changed to a new bioburden test method IDJ(4J I since the original validation, which can significantly affect recovery efficiency. You provided method suitability data fro n1DJ l4J I and lDll4J I Estradiol pellets packaged iIUIJ14I vials produced from your Lakewood, CO facility. You also provided method suitability data for mJ (4J I vials. These studies.
Observation 2 — Your firm failed to establi sh adequate written procedures for production and
Your firm failed to establi sh adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. Specifically, SOP 12, Visual inspection ofPellets (BSO Lakewood & Golden), Version 26.0, Effective Date 03/19/2025, does not have defined criteria for operator re-qualification outside oflDJ14J lretraining , particularly in cases where re-qualification may be warranted due to performance issues, process deviations, or procedural changes. As a result, operators may remain in a qualified status despite demonstrating issues performing critical operations, without any reassessment of their competency. For exampl e: EMPI.OYEE(S) SIGNATURE OATE ISSUEO SEE REVERSE Lucila B Nwatu , I n ves t i ga t or/Co n s um er 6/27/202 5 OF THIS PAGE Safety Office r .....luc:1111 _.,.,..,.,...., 8 "-ll;I ...,., ~~~~~,.._TU • X FORM FDA ~83 (09/08) PREVIOUS EDmO N OBSOLEJE INSPECTIONAL OBSERVATIO NS PAGE 2 of !0 PAGES
Observation 3 — The written stability program for drug products does not include specific test
The written stability program for drug products does not include specific test methods. Specifically, a.Lack of Photostabili!l: Studies for Lii:;ht-Sensitive Product: Your firm manufactures Estradiol pellets, which are light-sensitive product, yet the product is packaged and released in clear, non- light-resistant containers. Stability Study BSO.SS.001 , Estradiol Pellet Stability Study- Day Report, si gned 03/24/2025, does not contain any data to demonstrate that the packaging protects EMPI.OYEE(S) SI GNATURE OATE ISSUEO SEE REVERSE Lu cila B Nwa tu , I n vest i gat o r /Co n sumer 6/2 7 / 2 0 25 OF THIS PAGE Safe t y Offi c e r .....luc:11118"-ll;I _.,.,..,.,...., ...,., ~~~~~,.._TU • X PAGE4 of !0 PAGES FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIO NS
Observation 4 — Testing and release of drug product for distribution do not include appropriate
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. Specifically, Your firm manufactures Estradiol Pellets (6 mg, 10 mg, 12.5 m g, 15 mg, 18 mg, 20 mg, 25 mg, 37.5 mg, 50mg) intended for subcutaneous implantation, designed to release drug over a prolonged period. However, you do not perform dissolution testing as part of batch release. This omission of disso lution testing could potentially lead to the distribution of subpotent drug products, as well as potential dose dumpin g, inconsistent release rates, and incomplete drug release. EMPI.OYEE(S) SI GNATURE OATE ISSUEO SEE REVERSE Lu cila B Nwa tu , I n vest i gat o r /Co n sumer 6/2 7 / 2 0 25 OF THIS PAGE Safe t y Offi c e r .....luc:11118"-ll;I _.,.,..,.,...., ...,., ~~~~~,.._TU • X FORM FDA ~83 (09/ 08) PREVIOUS EDmO N OBSOLEJE INSPECTIONAL OBSERVATIO NS PAGE.
Observation 5 — Equipment used in the manufacture, processing, packing or holding of drug products
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations fo r its intended use. Specifically, The ._.........__ _, (BSO-016), used in the production of Estradiol granulate at the firm, has not been qualified with respect to its ability to remove residual solvents. Estradiol granulate conta· as a granulating solvent. The equipment qualification study (BSO.EQ.016.lR..............._______ ____, ) for this ._.l,A,;;__ _, was performed using (lj) (4) and ( 6) (4)and did not evaluate performance using No study was provided to demonstrate equivalency between the qualification materials and the actual product formulation. No data were provided to demonstrate that th is capable of consistently and safely removin...._............. under the parameters used during routine production. Your firm provided residual s ol vent test data and ._.........__ _, qualification results from a different facility under the same corporate ownership (BSO.ST.009.1); however, no on site residual solvent testing was performed at this location to.
Observation 6 — The master production and control records are deficient in that they do
The master production and control records are deficient in that they do not include complete manufacturing and control instructions, speci fi cations, special notations and precautions to be followed. Specifically, EMPI.OYEE(S) SI GNATURE OATE ISSUEO SEE REVERSE Lu cila B Nwa tu , I n vest i gator/ Co n sumer 6/2 7 / 2 0 25 OF THIS PAGE Safe t y Offi c e r FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIO NS PAGE6of !0 PAGES
Observation 7 — Written production and process control procedures are not followed in the execution
Written production and process control procedures are not followed in the execution of production and process control functions. Specifically, Section 7.1.3.1 of SOP 58, In-Process, We ight, and Hardness Sampling for Pellets (BS O- Lakewood & Golden), Version 25, E ffective Date 02/07/2025, states "Regardless of weighing metho d, documentation will occur o ._....._____ __, pellets pressed ... " . The following deviations from this procedure were observed on 06/19/2025, during the production ofE stradiol 15 mg Pellets, Lot ·--..i..a.;;.;...__ _, a.Incorrect Sampling Freguency: Technicians conducted in-process checks every 25 pellets instead of eve.TUI!'•- pellets as specified in the SOP and Estradiol Pellet Manufacture Batch Production Record- Form 46-12E. b.lncomplete Documentation: Midway through the production of the batch, Technicians stopped EMPI.OYEE(S) SI GNATURE OATE ISSUEO SEE REVERSE Lu cila B Nwa tu , I n vest i gat o r /Co n sumer 6/2 7 / 2 0 25 OF THIS PAGE Safe t y Offi c e r FORM.
Observation 8 — Written procedures are not followed for the cleaning and maintenance of equipment
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, On 6/ 17/2025, I observed th ._.1,,,11,,,,i...._. cleaning process for ISO 8 Inspection Room, where Estradiol pellets are weighed, vialed, and capped, and n oted the following deviation s: a. Improper Floor Cleaning Technigue: During floor cleaning with sporicidal agent, Technician id not follow the method outlined in Section 8.2.2 of WI 163. 01 , Cleanroom Cleaning 1 ecnniques (BSO-Golden), Version 2.0, Effective Date 01/06/2025, which require --..~L.-1 fr om ......'-&..aL----...., an ..._.........,..._____ __, . Section 8.2. 9. 2 of SOP 163, Cleaning/Sanitation ofFacility/Cleanroom (BSO-Golden), Version 6.0, Effective Date 05 /21/2025, states "Enter and clean at locatio ._.....,_._____ __, to avoid waling on clean surf aces." Instead, the technician stepped on wet floor surfaces immediately after ._.i..a......_. and placed chairs and tables directly on top of treated areas without allowing for the required.
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
BSO, LLC’s FDA history
Argus HQ has recorded 2 total FDA actions tied to BSO, LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- Has BSO, LLC had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to BSO, LLC, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3030548360.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
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Related enforcement actions
Full FDA history for BSO, LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). Form 483 Record: BSO, LLC, June 27, 2025 — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-bso-llc-2025-06-27-3030548360
"Form 483 Record: BSO, LLC, June 27, 2025 — 8 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-bso-llc-2025-06-27-3030548360.
Argus HQ Research. "Form 483 Record: BSO, LLC, June 27, 2025 — 8 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-bso-llc-2025-06-27-3030548360.
@misc{argushq_argushq_ai_483_fda_483_bso_llc_2025_06_27_3030548360_2025,
title = {Form 483 Record: BSO, LLC, June 27, 2025 — 8 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-bso-llc-2025-06-27-3030548360},
note = {Accessed: July 13, 2026}
}