What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

Has Micro Labs Limited had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Micro Labs Limited so far. Argus ingests new FDA records daily.

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

FEI / inspection ID: 3004495158.

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.

Form 483 Record: Micro Labs Limited, February 7, 2025

At a glance: FDA inspected Micro Labs Limited in India and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-02-07. FDA records classify Micro Labs Limited as a finished drug product 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.

Key facts

Firm	Micro Labs Limited
FEI / inspection ID	3004495158
Inspection end date	February 7, 2025
Citation count	3

Citations explained

Observation 1 — The responsibilities and procedures applicable to the quality control unit are not

The responsibilities and procedures applicable to the quality control unit are not in writing and fully fo llowed. Specifically, Your Quality Unit lack oversight on the control and management of GMP documents that are critical in ensuring drng products manufactured and tested at your site are safe and effective. For example, at the initiation of this inspection on 30-Jan-2025, we observed that one of your housekeeping personnel was rnshing to remove large black color plastic scrap bags fr om the main QC Chemistiy laborato1y. This scrap bag was collected fo r our evaluation. Sub se quently, large number of transparent plastic bags along with few silver and green color plastic bags containing black color scrap bags were fo und in the main scrapyard of your facility. The evaluation of these scrap bags reveal ed large number of tom and few intact pieces of GMP documents indicative of original records, raw data, and metadata such as "Leak Tester Results" printouts, pH.

Observation 2 — Laborato1y controls do not include the establishment of scientifically sound and appropriate

Laborato1y controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and diug products con fo1m to appropriate standards of identity, quality and purity. Specifically, Your l (b)-c1- test procedure L ~ )14 • g fo r Relative Content of Y{4 'u"~t by GC-FID is deficient and the ana yses conducted according to t 1s test Iprocedure does not ensure integrity of test results. Some examples include: EMPLOYE E($) SIGNATURE DATE lSSUEO P ra tik S Upa d h yay, In ve sti ga to r 2/7/202 5 SEE REVERSE Fnal 8 ~ Timo t h y H Vo , I n ve s ti g at o r OF THIS PAGE Slo'led8'1::F'Rf.TIK:a "6'IO-tYAY-8 011e: ~m•on ms 0 3:)11:32 X

Observation 3 — Equipment and utensils are not cleaned and maintained at appropriate intervals to

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, i de ntity, s b.'ength, qua li ty or purity of the diug product. Specifica lly, During the facility walkthrough on Januaiy 31st, 2025, we observed that your Quality and Production Units lacked oversight on the adequate cleaning and maintenance of equipment that ai·e used in the manufacturing of diug products at your si te. For example, I.The I CbTC4l belt number PR 049 had an unidentified piece of debris on top of the conveyor bel t. The debris had ~ (bT, appearance and was approximatel~ to ,n mm in length and ~ to Ej mm in width. Your equipment cleaning record shows that type A (product to product) EMPLOYE E($) SIGNATURE DATE lSSUEO P ra tik S Upa dh yay, In ve sti ga to r 2/7/202 5 SEE REVERSE Fnal 8 ~ Timo t h y H Vo ,.

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.

Micro Labs Limited’s FDA history

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

Frequently asked questions

What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has Micro Labs Limited had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Micro Labs Limited so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3004495158.
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.

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Full FDA history for Micro Labs 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 (2025). Form 483 Record: Micro Labs Limited, February 7, 2025 — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-micro-labs-limited-2025-02-07-3004495158

MLA

"Form 483 Record: Micro Labs Limited, February 7, 2025 — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-micro-labs-limited-2025-02-07-3004495158.

Chicago

Argus HQ Research. "Form 483 Record: Micro Labs Limited, February 7, 2025 — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-micro-labs-limited-2025-02-07-3004495158.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_micro_labs_limited_2025_02_07_3004495158_2025,
  title = {Form 483 Record: Micro Labs Limited, February 7, 2025 — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-micro-labs-limited-2025-02-07-3004495158},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗