Drug factory · FDA FEI 3004710309

Carilion Materials Management

Roanoke, Virginia, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

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.

Feb 14, 2018 inspection

• Approval and review of procedures 21 CFR 211.100(a)
  Written procedures are not reviewed and approved by the quality control unit.
• No written record of investigation 21 CFR 211.192
  Written records are not made of investigations into unexplained discrepancies.
• Record information inclusions 21 CFR 211.204
  Records of returned drug products do not include the lot, control or batch number, reason for return, date of disposition and ultimate disposition.
• 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.

Mar 2, 2011 inspection

• Quality control - ensure quality; package, labeled, master record 21 CFR 111.105
  Your quality control personnel did not ensure that your packaging operations ensure the quality of the dietary supplement.
• Quality control - reserve samples 21 CFR 111.105(g)
  Your quality control personnel did not ensure that required reserve samples were collected and held.
• Personnel - education, training, experience 21 CFR 111.12(c)
  Personnel engaged in packaging dietary supplements do not have the education, training, or experience to perform the person's assigned functions.
• Quality control operations - components, packaging, labels 21 CFR 111.120
  You do not have quality control operations for components and packaging before use in the manufacture of a dietary supplement.
• Document-equipment date of use, maintain, clean, sanitize 21 CFR 111.35(b)(2)
  You did not make and keep documentation of maintenance of the equipment.
• Labels - issuance, use 21 CFR 111.410(b)
  You did not control the issuance and use of labels,
• Dietary supplement - protect, contamination 21 CFR 111.415(b)
  You did not protect manufactured dietary supplements from contamination during packaging operations.
• Written procedures - product complaint 21 CFR 111.553
  You did not establish written procedures for the requirements to review and investigate a product complaint.
• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs.
• 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.
• Records of any sampling performed 21 CFR 211.188(b)(10)
  Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.
• Inspection of packaging and labeling area 21 CFR 211.188(b)(6)
  Batch production and control records do not include results of the inspection of the packaging and labeling area before and after use for each batch of drug product produced.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
• 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.
• 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, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
• 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.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, approval, and rejection of components and drug product containers.