Drug factory · FDA FEI 3011690045

Direct Rx

94 World Wide Drive Suite 110, Dawsonville, GA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Dec 15, 2017 inspection

• Returned drug products identified and held 21 CFR 211.204
  Returned drug products are not identified as such and held.

Aug 13, 2015 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Written warehousing procedures established/followed 21 CFR 211.142
  Procedures describing the warehousing of drug products are not followed.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.

Registered with FDA for: relabel; repack.