FDA Inspection
Holly Oak Chemical, Inc.Holly Oak Chemical, Inc. – FDA Inspection, Apr 25, 2017
Record Details
This FDA Inspection record concerns Holly Oak Chemical, Inc., with an inspection on April 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8f005ca1-8c28-4e07-bb55-cc1a706db53b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019255
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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