Drug factory · FDA FEI 2000009210

PLD Acquisitions LLC D/B/A Avema Pharma Solutions

10400 NW 29th terrace, Miami, FL, 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.

Jan 30, 2019 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.
• 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
  Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Apr 23, 2014 inspection

• Personnel - education, training, experience 21 CFR 111.12(c)
  Personnel engaged in manufacturing, packaging, labeling, and holding dietary supplements do not have the education, training, or experience to perform the person's assigned functions.
• Procedures - equipment - cleaning, sanitizing 21 CFR 111.25(c)
  You did not establish and follow written procedures for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
• Examination, testing; appropriate 21 CFR 111.320(a)
  You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use.
• Conditions, controls -protect; microorganisms, contamination 21 CFR 111.365(a)
  You did not perform manufacturing operations under conditions and controls that protect against the potential for contamination.
• Testing Calculations 21 CFR 211.194(a)(5)
  Laboratory records are deficient in that they do not include all calculations performed during testing.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: manufacture; pack.