FDA Inspection
O.C.C.S. Inc.O.C.C.S. Inc. – FDA Inspection, Apr 29, 2022
Record Details
This FDA Inspection record concerns O.C.C.S. Inc., with an inspection on April 29, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- O.C.C.S. Inc.
- Inspection Date
- April 29, 2022
- Product Type
- Drugs
View Company Profile
ID · 30315412-40f5-4621-a479-7330e8e9e5d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1168388
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.22(a)Lack of quality control unit
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