Drug factory · FDA FEI 3014617112

Vero Biotech Inc.

387 Nerem Street NW, Suite 125, Atlanta, GA, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 12, 2022.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitric Oxide	Makes it	Vero Biotech, Inc.	72385-001, 72385-002, 72385-003

Ended	Result	Program	Problems noted
Aug 12, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	4

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

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Design changes - Lack of or Inadequate Procedures 21 CFR 820.30(i)
Procedures for design change have not been adequately established.

Registered with FDA for: analysis; manufacture.