FDA Inspection
Dhaliwal Laboratories LLCDhaliwal Laboratories LLC – FDA Inspection, Dec 8, 2009
Record Details
This FDA Inspection record concerns Dhaliwal Laboratories LLC, with an inspection on December 8, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dhaliwal Laboratories LLC
- Inspection Date
- December 8, 2009
- Product Type
- Drugs
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ID · ba539fab-7018-4780-9632-60ba9591d60c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 633326
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.25(c)Inadequate number of personnel
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| June 14, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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