What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3004094136.

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.

What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

FDA Form 483 — Global Calcium Private Limited (February 3, 2026)

Key facts

Firm	Global Calcium Private Limited
FEI / inspection ID	3004094136
Inspection end date	February 3, 2026
Citation count	5

The short version: FDA inspected Global Calcium Private Limited in India and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2026-02-03. FDA records classify Global Calcium Private Limited as a active pharmaceutical ingredient manufacturer. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

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 — Laboratory records do not include comp lete data derived from all t

Laboratory records do not include comp lete data derived from all t es ts, exa minations and assay necessary to assure compliance with established specifications and standards. Specifically, Microbiology laboratory data is unreliable. For example, the fo ll owing discrepancies were observed between the individual microbial growth counts recorded in your laboratory-controlled records and the actual counts observed in your growth media plates, whi ch had been re.ad by your microbiologists. On January 27, 2026, and January 28, 2026, we observed that your microbiologist while performing Total Aerobic Microbial Count (TAMC) for(b)(4) Water(b)(4) did not count all colonies, combined separate colonies counts 1 as one and failed to classify plate counts as Too Numerous to Count (TNTC). For example, I Media ID: _!_ Incubation Date: (b)(4) I I Reoorted: Observed Deficiencv: 4 CbH >c_F_u___-1,-_c_o..:..n;...1b_i.;;..n_e_d·c_o_1o_n.:...ie-'-s_,_ra_i_le_d---i __ to count all co lonies. --(b)(4)CFU Comb in ed colonies, failed l to count all colonies. CbH4fFU Combined colonies, failed I to count all colonies..

Observation 2 — Established sampling plan and t est procedures are not fo llowed

Established sampling plan and t est procedures are not fo llowed. Specifically, we reviewed the biometric access control system (eSSL Security at Fingertips) for the Room (b)(4) (b)(4) located in Plant(b)(4)in where the(b)(4) water system is located, and water samples are collected. We observed the fo ll owing deficiencies: EW'LOYEE(S) NAME AND TITLE //'tint or Typo) DATE ISSUED SEE REVERSE Alan A. Rivera, Investigator , ; ~ i)J OF THIS . Jose E. Me lendez, DDC Investigator February 3, 2026 PAGE FORM FD A 03 (09108)

Observation 3 — Laboratory controls do not include the esta bH shment of scientifica ll

Laboratory controls do not include the esta bH shment of scientifica ll y sound and appropriate test procedures designed to assure th at in-process materials conform estab li shed specificlltions. Specifically, on January 28, 2026, we observed the preparation and reading of the Bacterial Endotoxin Test (BET) following your procedure titled 11 Bacterial Endotoxin Test", SOP Number: QCMIO 11-00, Effective Date: April 17, 2025. It was observed that your finn failed to provide the conditjons needed (no vibration) to prevent disturbance of the samples. during incubation and allow proper gel formatio n. Incubator (ID: QCMIE002) was observed vibrating during the/bH4) incubation period of routinelbH4) Water samoling points: (b)(4)(b)(4) Additic,nully, a semi solid ge l fonnalion was observed fo r water points CbH4) reported as negative result. Also, gel formation was observed in water point (b)(4) but since "tears" of liquid was observed running down the test tube, the analyst Glassified the sample as a negative BET result. According to your.

Observation 4 — Clea ning procedures are not appropriate or reproducible to prevent contamination that

Clea ning procedures are not appropriate or reproducible to prevent contamination that would alter the safety, identity, strength, quality, or purity of the finish ed drug substances. Your (b)(4) ~leaning activities for non-dedicated (b><4> Iocated •ms1.de Plant (b)(4) and used in the manufacturing of(b)(4) API are not reproducible. For example, but not limited to: 1) Accordi ng to your procedure ti tled "Equi~me~t Cleaning Record for(b)(4) \ Document Number: PD033-F0l(V-1), Operation Number(b) lates" (b) (4) '. On February 2, 2026, your operator replicated the clea ning procedures of th is step an d explained that the clea nin g process starts by (b)(4) '--"- (b)(4) The total vo lume of (b)(4l used on each step is random and is not documented, o nl y the combined volume of (b)(4) used in all (b)(4) steps is documented and required by the cleaning instnictions. In addition, your operator demon strated that the (b)(4) of the(b)(4) (b)(4) (bH4> w it h a capacity.

Observation 5 — The res pon sibilities of your Qua li ty Uni t are

The res pon sibilities of your Qua li ty Uni t are not full y followed A. Your Quality Unit failed to fulfill its commitment to conduct a comprehensive retrospective assessment by a third party of all batches manufactured during the calendar years 2022 to 2024. For example, your firm did not conduct a comprehensive evaluation of the manufacturing records as sociated to all batches manufactured for the USA market to determine the extent of the breaches in data integrity cited during the previous inspection on August 2, 2024, and WL 320-25-30. Your review provides no assurance that a reconciliation ofinco0;1ing raw materials and API produced and released, inventory, equipment use logbooks, test results, samples collected, and batch production records among others were evaluated to determine if additional discrepancies in the manufacturing operations had occurred as cited in WL 320-25-30. Instead, and without a justification, your Quality Unit followed th e statistical approach of (b)(4) (b)(4) to evaluate. the production.

Global Calcium Private Limited’s FDA history

Argus HQ has recorded 1 total FDA action tied to Global Calcium Private Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3004094136.
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.
What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

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Full FDA history for Global Calcium Private Limited

Compiled 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.

APA

Argus HQ Research (2026). FDA Form 483 — Global Calcium Private Limited (February 3, 2026) — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-global-calcium-private-limited-2026-02-03-3004094136

MLA

"FDA Form 483 — Global Calcium Private Limited (February 3, 2026) — 5 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-global-calcium-private-limited-2026-02-03-3004094136.

Chicago

Argus HQ Research. "FDA Form 483 — Global Calcium Private Limited (February 3, 2026) — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-global-calcium-private-limited-2026-02-03-3004094136.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_global_calcium_private_limited_2026_02_03_3004094136_2026,
  title = {FDA Form 483 — Global Calcium Private Limited (February 3, 2026) — 5 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-global-calcium-private-limited-2026-02-03-3004094136},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗