Drug factory · FDA FEI 3011895410

Apl Healthcare Limited

Unit-IV, Plot No.16, 16 – A, APIIC, M.P.Sez, Menakuru Village, Naidupeta Mandal, Tirupati District, Tirupati, India

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 17, 2025 inspection

• Test methods 21 CFR 211.165(e)
  The accuracy of test methods have not been established and documented.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning SOPs/equipment identification 21 CFR 211.67(b)(4)
  Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.

Registered with FDA for: analysis; manufacture.