FDA Inspection
Analys Lab Private LimitedAnalys Lab Private Limited – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Analys Lab Private Limited, with an inspection on December 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Bapu R. Gaddam (Issuing Officer)
- Darren S. Brown (FDA Associated Person)
- Mark C. Saale (FDA Associated Person)
View Company Profile
ID · 28d36300-c8c7-4244-976d-e7acd00079e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075861
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Analys Lab Private Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Analys Lab Private Limited
- FDA Inspection 1204992 - 2023-04-14
- FDA Inspection 1037554 - 2017-11-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.