Drug factory · FDA FEI 1831143

Northwind Health Company, LLC

4838 Fletcher Ave, Suite 1000, Indianapolis, IN, 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.

Sep 26, 2025 inspection

• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Dec 9, 2015 inspection

• Penicillin processing area not kept separate 21 CFR 211.42(d)
  The operations relating to the packing of penicillin are not performed in facilities separate from those used for other drug products for human use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Sep 14, 2015 inspection

• Description of containers and closures 21 CFR 211.188(b)(9)
  Batch production and control records do not include a description of drug product containers and closures used for each batch of drug product produced.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed .
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Testing Containers & Closures Conformity with Specs 21 CFR 211.84(d)(3)
  Containers and closures are not tested for conformance with all appropriate written procedures.

Registered with FDA for: relabel; repack.