Key facts
| Firm | BSO, LLC |
|---|---|
| FEI / inspection ID | 3011976853 |
| Inspection end date | July 16, 2025 |
| Citation count | 7 |
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.
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile did not include adequate validation of the sterilization process. Specifically, a. Lack of Potencl'. Data at Maximum Sterilizin2 Dose Ran2e: Under RAM 24008, dated 08/1 4/2024, your fnm changed the container-closure system for all doses less than 87.5 m ftio f Anastrozole, Estradiol, Testosterone, and Testosterone with Cholesterol pellets fr om i l5) (4)i [ IAmber Vials to [( b (4) JClear Vials. You per fo1med a b) (4 ) I(BSO04 dated 05 /06/2024) showing that the sterilizing dose increased from ( b) (4) to ( b) (,4) 1- However, your fnm did not assess the impact of this sterilization range on product quality in the revised container-closure system. Specifically, you were unable to provide pre- and post-sterilization potency data fo r Anastrozole and Estradiol products packaged in clear vials. Instead, in BSO.ST.034.1, Potency/Sterilization Study Results (signed 11/14/2024), your fnm used products packaged in amber glass vials,.
Observation 2 — Employees engaged in the manufacture and processing of a drng product lack
Employees engaged in the manufacture and processing of a drng product lack the training required to perfo1m their assigned functions. Specifically, The[(6) -(~) Iused to train and evaluate personnel perfo1ming the visual inspection of liquid injectable products is incomplete. Revi ew of Fo rm 190-02, Liauid Injectables [(6) (4) I Inventory (BSO Lakewood and Golden) fo und that the [(b) (4 '7 does n ot contam examples of all critical de fe cts, including: "Improper crimp (not gripping the lip of the vial)" and "Stopper on vial crooked or compromised". This [(b) (4) Iis intended to se1ve as the reference libra1y of vials from which the b) (4) J ■ are createa to assess the proficien cy of visual inspectors. The absence of representative examples of all critical container-closure integrity defects prevents adequate demonstration that personnel can consistently identify defects which pose a risk to product sterility. Liquid Injectable products include Testosterone Cypionate/ Anastrozole 20 0mg/0.5 mg; Testosterone Cypionate/ Anastrozole.
Observation 3 — Your fum failed to establish adequate written procedures for production and process
Your fum failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, stren gth, purity, and quality that they are purpolied or represented to possess. AMENDMENT 1 EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Lucila B Nwa t u, I nves t iga t or/Consumer OF THIS PAGE Safe t y Officer =- 7/ 1 6/2025 .....LuC:1111 8 ...... ~UJCILA8.N\WI.TU4 X strutOT-16-202S 11:3".25 - INS PEC TIONAL OB SERVATIONS PAGE 3 of ll PAGES F ORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE
Observation 4 — The written stability program does not assure testing of the dmg product
The written stability program does not assure testing of the dmg product in the same container-closure system as that in which the dmg product is markete d. Specifically, AMENDMENT 1
Observation 5 — The written stability program fo r diug products does not include specific
The written stability program fo r diug products does not include specific test methods. Specifically, Dmg products are not tested for critical quality attributes to ensure they maintain their identity, strength, quality, and purity throughout the expiiy period. a. Lack of Photostabili:!Y Studies for dru2 l?roducts stored in clear containers that mal'. be li2ht sensitive: Your fnm manufactures the following light-sensitive products, and are packaged & and releas ed in clear, non-light-resistant containers. Your stability studies oor 1.VP/PQ003. l .VR and BSO.SS.008.lP-RT.TC_A_DHEALiquidlnjectables- (4) S lllll1ll aiy) do not contain any data to demonstrate that the pack aging protects the diug from photodegradation. No photostability studies have been per fo1med on the di11g product in its container-closure system to demonstrate its protection from ligh t. Failure to demonstrate photostability increases the risk of degradation and reduced potency or alter ed safety profile during distribution and sto ra ge. • Est ra diol (6 mg, 10 mg, 12.5 mg, 15 mg, 18.
Observation 6 — Testing and release of d rng product for distribution do not include
Testing and release of d rng product for distribution do not include appropriate laborato1y dete1mination of satisfacto1y confo1mance to the final specifications prior to release. Specifically, a. Lack of Di ssolution testing: Your fom does not peifo1m dissolution testing to evaluate the diug release characteristics of the fo llowing products. Without dissolution testing, there is no assurance that these products will release the active ingr edient at the intended rate and extent, which may result in sub-therapeutic dos ing or diug toxicity. • Anastrozole (6 mg) pellets • Estradiol (6 mg, 10 mg, 12.5 mg, 15 mg, 18 mg, 20 mg, 25 mg, 37.5 mg, 50 mg) pellets • Progesterone (50 mg, 75 mg) pellets • Testosterone (12.5 mg, 25 mg, 37.5 mg, 50 mg, 62.5 mg, 70 mg, 80 mg, 87.5 mg, 100 mg, 200 mg BLNT) pellets • Testosterone/< 2 % Cholesterol (100 mg, 200mg, 200 mg BLNT) pellets • Testosterone/< 4 % Cholesterol (12.5 mg, 25 mg,.
Observation 7 — AMENDMENT 1 EMPLO YEE(S) SI GNATURE DATE ISSUED SEE REVERSE Lu c
AMENDMENT 1 EMPLO YEE(S) SI GNATURE DATE ISSUED SEE REVERSE Lu c i l a B Nwa t u, I n ve s t i g a t o r /Cons umer 5 OF THIS PAGE S afe t y Offi c er .....- 7 / 1 6/202 = LuC:1111 8 ...... ~ UJCILA- 8. N\WI.TU4 X strut OT-16-202S 11:3".25 F ORM FDA ~83 ( 09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OB SERVATIONS PAGE 10 of ll PAGES
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: 3011976853.
- 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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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). BSO, LLC — FDA Form 483 Inspection, July 16, 2025 (7 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-bso-llc-2025-07-16-3011976853
"BSO, LLC — FDA Form 483 Inspection, July 16, 2025 (7 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-bso-llc-2025-07-16-3011976853.
Argus HQ Research. "BSO, LLC — FDA Form 483 Inspection, July 16, 2025 (7 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-bso-llc-2025-07-16-3011976853.
@misc{argushq_argushq_ai_483_fda_483_bso_llc_2025_07_16_3011976853_2025,
title = {BSO, LLC — FDA Form 483 Inspection, July 16, 2025 (7 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-bso-llc-2025-07-16-3011976853},
note = {Accessed: July 13, 2026}
}