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FDA Inspection
•Mid-Continent Packaging, Inc•January 24, 2013

Mid-Continent Packaging, Inc – FDA Inspection, Jan 24, 2013

Record Details

This FDA Inspection record concerns Mid-Continent Packaging, Inc, with an inspection on January 24, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mid-Continent Packaging, Inc
Inspection Date
January 24, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · c53b771f-6357-4c8b-8402-faab7b13cd2e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
815531
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

12
  1. 21 CFR 211.103Actual vs. theoretical yields not determined
  2. 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
  3. 21 CFR 211.192Quality control unit review of records
  4. 21 CFR 211.160(b)Scientifically sound laboratory controls
  5. 21 CFR 211.184(c)Individual inventory record
  6. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  7. 21 CFR 211.170(b)Reserve samples identified, representative, stored
  8. 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
  9. 21 CFR 211.186(a)Signature and checking of records -- 2 persons
  10. 21 CFR 211.100(a)Absence of Written Procedures

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mid-Continent Packaging, Inc

1
DateClassificationOfficeProject area
March 7, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mid-Continent Packaging, Inc
  • FDA Inspection 1164031 - 2022-03-07

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