FDA Inspection
Universal Manufacturing CorpUniversal Manufacturing Corp – FDA Inspection, Aug 27, 2009
Record Details
This FDA Inspection record concerns Universal Manufacturing Corp, with an inspection on August 27, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Universal Manufacturing Corp
- Inspection Date
- August 27, 2009
- Product Type
- Drugs
View Company Profile
ID · a74a1a68-5f05-4b28-8325-9193e86bba2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606931
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.110(a)Written in-process control procedures
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