FDA Inspection
Makson Health Care Private Ltd.Makson Health Care Private Ltd. – FDA Inspection, Sep 29, 2022
Record Details
This FDA Inspection record concerns Makson Health Care Private Ltd., with an inspection on September 29, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 29, 2022
- Product Type
- Drugs
View Company Profile
ID · 2311e735-a723-4b95-8aed-fbed05bcbe6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1181457
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Written Procedures Not Followed
Full citation text and observation details available on the Dashboard.
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.